Z-0500-2018Class II

bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G)...

Name: Z-0500-2018 bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G)...
Creator: Beaver-Visitec International Inc.
Published: 2017-11-03
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2017-11-03 / Terminated / root cause: manufacturing process

FDA source

Beaver-Visitec International Inc. began a recall of bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 Product Usage: Specialty blades and... on 2017-11-03. FDA classified it as Class II and gives the reason as "The protective shield was retracted, and the blade was exposed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0500-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-03
Posted: 2018-02-01
Terminated: 2023-05-31
Recalling firm: Becton Dickinson & Co
Product: bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
Product code: EMF Knife, Surgical
Reason for recall: The protective shield was retracted, and the blade was exposed.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm disseminated their safety advisory notices on 11/03/2017 by email and visit. The letter identified the affected product, problem and actions to be taken. The firm requested the following action:"Prior to opening the Tyvek tray, please visually confirm that the plastic shield is not retracted and the activation slider is fully engaged."
Quantity in commerce: 45, 680 units
Distribution: Worldwide Distribution - US Nationwide and the countries of Italy, UK, Finland, Germany, Ireland, Turkey
Product codes and lots: (a) REF 370531; Batch numbers: 3185248 3191981 3193837 3199247 3201734 3204737 3206382 3208096 3211720 3213361 3214546 3217371 3219431 3222626 3225976 (b) REF 378233; Batch numbers: 3191985 3204382 3225442

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0500-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0500-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-02-01
Z-0501-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-02-01
Z-0502-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-02-01
Z-0503-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-02-01
Z-0504-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-02-01

Product code EMF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)